Back to results

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Primary Purpose

Diabetic Neuropathies, Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Comparator: Active tDCS + Active TUS

Sham

About this trial

This is an interventional treatment trial for Diabetic Neuropathies

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Able to provide informed consent to participate in the study.
Subjects between 40 to 80 years old.
Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
Must have the ability to feel pain as self-reported.

Exclusion Criteria:

Subject is pregnant.
Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
History of alcohol or drug abuse within the past 6 months as self-reported.
Use of carbamazepine within the past 6 months as self-reported.
Suffering from severe depression (with a PHQ 9 score of ≥ 10).
History of neurological disorders as self-reported.
History of unexplained fainting spells as self-reported.
History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
History of neurosurgery as self-reported.
Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).

Sites / Locations

Ciro Ramos EstebanezRecruiting
University Hospitals Cleveland Medical Center/ Dahms Clinical Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Comparator: Active tDCS + Active TUS

Sham

Arm Description

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Outcomes

Primary Outcome Measures

Changes in pain as measured by the Visual Analog Scale (VAS)

The scale will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Changes in VAS for Pain will be measured to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.

Secondary Outcome Measures

Changes in the Verbal Rating Scale (VRS) for Pain

The VRS for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity. Changes in VRS for Pain will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction. with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.

Changes in Conditional Pain Modulation

Changes in Conditional Pain Modulation (CPM) will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in increasing the pain pressure threshold in subjects with diabetic neuropathic pain.

Changes in Visual Analog Scalefor Mood (VAMS)

The VAS for Mood will investigate Anxiety, Depression, Stress, and Sleepiness. The Subscales are as follows: The anxiety scale will assess a patient's anxiety on a scale from 0 (not anxious) to 10 (very anxious). The depression scale will assess a patient's depression on a scale from 0 (not depressed) to 10 (very depressed). The stress scale will assess a patient's stress on a scale from 0 (not stressed) to 10 (very stressed). The sleepiness scale will assess a patient's depression on a scale from 0 (not sleepy) to 10 (very sleepy).

Montreal Cognitive Assessment

The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition. Scores range from lowest being 0 to highest being 30.

4-choice reaction time

This is an attentional task that measures the time for a subject response to stimuli (in seconds) with shorter times being better.

N-back tests

Assesses registration and immediate recall on a scale of the number of items correctly responded to

Electroencephalography

Investigators will measure electroencephalogram (EEG) electrical activity (EEG amplitude and EEG frequency) as function of time.

Walking test

The investigators will measure if there are changes in the walking speed, gait asymmetry, stride length, and walking smoothness of the subject from the beginning of the study to the end

Functional reach test

The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.

Study 36-Item Short Form (SF-36)

This is a health survey using a scale from 0 (worst) to 100 (best)

Patient Health Questionnaire (PHQ-9)

This questionnaire screens for depression with a score of 0 (best) to 27 (worst)

American Pain Foundation Pain and Medication Diary

The pain sub-scale measures pain intensity from 0 (best) to 10 (worst)

Multidimensional Pain Inventory (MPI)

This pain scale measures aspects of pain from 0 (best) to 6 (worst)

Brief Pain Inventory-DPN

This pain scale measures aspects of pain from 0 (no pain) to 10 (worst)

Adverse events

At each session after stimulation begins, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale (0 being best and 5 worst). The scale will also be administered at the follow-up.

Full Information

NCT ID

NCT03625752

First Posted

July 27, 2018

Last Updated

September 5, 2023

Sponsor

Case Western Reserve University

Collaborators

Highland Instruments, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03625752

Brief Title

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Official Title

Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2019 (Actual)

Primary Completion Date

June 7, 2024 (Anticipated)

Study Completion Date

May 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Case Western Reserve University

Collaborators

Highland Instruments, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.

Detailed Description

Active stimulation will be compared with compared to SHAM stimulation in DNP patients. 20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits). Subsequently, 40 DNP patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathies, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

single-center, double-blinded, placebo controlled, randomized study.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Comparator: Active tDCS + Active TUS

Arm Type

Active Comparator

Arm Description

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Intervention Type

Device

Intervention Name(s)

Active Comparator: Active tDCS + Active TUS

Intervention Description

Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Primary Outcome Measure Information:

Title

Changes in pain as measured by the Visual Analog Scale (VAS)

Description

Time Frame